510(k) K031506

ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY by Beckman Coulter, Inc. — Product Code LGD

K031506 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY". The FDA issued a decision of Substantially Equivalent on June 2, 2003. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.